Distributed neuro-modulation system with auxiliary stimulation-recording control units

ABSTRACT

Systems and methods for modulating a physiological process are provided to enable precise delivery of signals to a predetermined treatment site. The systems may comprise an implantable device and an electrical lead body. The electrical lead body may comprise a plurality of transducer contacts in close proximity to an end of the electrical lead body, and a control unit positioned within the lead body in close proximity to the plurality of transducer contacts.

FIELD OF THE DISCLOSURE

This disclosure relates to systems and methods of modulating aphysiological process. More particularly, this disclosure relates tosystems and methods of modulating a physiological process to enableprecise delivery of signals to a predetermined treatment site.

SUMMARY

In some embodiments of the present disclosure, a physiologicalelectrical lead body is provided. The physiological electrical lead bodymay comprise a plurality of transducer contacts in close proximity to anend of the electrical lead body and a control unit. The control unit maybe positioned within the lead body in close proximity to and incommunication with the plurality of transducer contacts. The controlunit may be constructed and arranged to enable precise delivery ofsignals to a predetermined treatment site. The control unit may compriseat least one electrical input contact, and a plurality of electricaloutput contacts, wherein a quantity of the electrical output contacts isgreater than a quantity of the electrical input contacts.

In some other embodiments of the present disclosure, a system formodulating a physiological process is provided. The system may comprisean implantable device comprising an energy source. The implantabledevice may be constructed and arranged to provide a signal. The systemmay also comprise an electrical lead body connected to the implantabledevice. The electrical lead body may comprise a plurality of transducercontacts in close proximity to an end of the electrical lead body, and acontrol unit positioned within the lead body in close proximity to theplurality of transducer contacts. The control unit may be constructedand arranged to enable precise delivery of signals to a predeterminedtreatment site. The control unit may comprise at least one electricalinput contact and a plurality of electrical output contacts, wherein aquantity of the electrical output contacts is greater than a quantity ofthe electrical input contacts.

In some other embodiments of the present disclosure, a method oftreating a condition in a subject is provided. The method may comprisegenerating a first input signal from an implantable device. The methodmay also comprise transmitting the first input signal from theimplantable device to a control unit positioned in an electrical leadbody comprising a first end and a plurality of transducer contacts inclose proximity to the first end. The method may also comprisegenerating a plurality of output signals based on the first input signalfrom the implantable device and on a control function of the controlunit. The method may also comprise transmitting the plurality of outputsignals from the control unit to the plurality of transducer contacts toprovide a precise delivery of signals to a predetermined treatment site.

DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, each identical or nearly identical component that isillustrated in the various figures is represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing.

In the drawings:

FIG. 1 is an illustration of an electrical lead body in accordance withone or more aspects of the disclosure;

FIG. 2A is an illustration of a system in accordance with one or moreaspects of the disclosure;

FIG. 2B is an illustration of a system in accordance with one or moreaspects of the disclosure;

FIG. 2C is an illustration of a system in accordance with one or moreaspects of the disclosure;

FIG. 2D is an illustration of a system in accordance with one or moreaspects of the disclosure;

FIG. 3A is an illustration of a portion of a system in accordance withone or more aspects of the disclosure;

FIG. 3B is an illustration of a portion of a system in accordance withone or more aspects of the disclosure; and

FIG. 3C is an illustration of a portion of a system in accordance withone or more aspects of the disclosure.

DETAILED DESCRIPTION

Systems and methods for modulating a physiological process are provided.The systems and methods may provide a more effective technique forneurostimulation or neuromodulation therapies. The systems and methodsmay be used for neurostimulation or neuromodulation in spinal cord,vagus nerve, deep-brain, and retinal applications. The systems andmethods may provide improved therapy or treatment by more tightlycontrolling or confining a signal or an electrical current to a desiredlocation, such as a target location, treatment area, or treatment site.The desired location or target location may be a location on a subject.The location may be a specific area of tissue. The systems and methodsmay provide for more tightly controlling or confining one or moreelectrical currents or signals from stimulus waveforms to a targetedtissue area or volume. The systems and methods may also provide forprevention or reduction of signals or electrical current from reachingundesired or non-targeted areas or volumes.

The systems and methods of the present disclosure may be utilized aloneor in combination with a larger system that may be used forphysiological treatment or for diagnostic purposes. The systems andmethods of the present disclosure may be utilized to gather informationor treat a subject over a predetermined period of time, or may be usedindefinitely to monitor or treat a subject. It may be used to monitor asubject, or control a physiological condition of a subject, or induce orblock a certain physiological event. One or more components of thesystems and methods of the present disclosure may be used in a wirelessconfiguration.

The systems and methods of the present disclosure also allow forelectrical current to be provided through a greater number of transducercontacts. This allows for a finer adjustment of the electrical currentby having a larger number of transducer contacts available to deliverthe electrical current and be in contact with the target location of asubject. For example, the present disclosure may allow for electricalcurrent or signals to be provided by having a greater number oftransducer contacts over the same surface area as a conventional systemhaving a given number of transducer contacts. The subject may be ananimal subject, for example a mammalian subject, or a human subject.

In some embodiments, this may be accomplished by using a controller orcontrol unit as presently disclosed. The control unit may enable theavailability of a larger number of transducer contacts to deliver theelectrical current or signals and be in contact with the target locationof a subject. The control unit may direct incoming stimulus waveformsfrom a number of input wires or filaments, that are in communicationwith a device such as an implantable device, to a number of output wiresor filaments that deliver electrical current or other signals to anumber of transducer contacts. The number of output wires or filamentsfrom the control unit that deliver current to a number of transducercontacts is typically greater than the number of input wires orfilaments. In certain examples, the number of input wires or filamentsfrom the device to the control unit may be between 4 and 8 wires orfilaments. In these examples, the number of output wires or filamentsfrom the control unit to the transducer contacts may be between 16 and64 or more. In conventional systems prior to this disclosure it was onlypossible to provide 4 to 16 input wires, and a corresponding 4 to 16output wires, leading to a corresponding 4 to 16 transducer contacts. Atleast one of the limiting factors in conventional systems is thediameter or width of the electrode lead, which in certain systems may beabout 2.0 mm or about 1.3 mm, and in some systems 1.27 mm. In certainapplications, the diameter or width of the electrode lead is controlledby the incision site and area through which the transducer contacts mustbe introduced.

The control unit may provide for the ability to have a greater number ofoutput wires or filaments than input wires or filaments. This may beaccomplished by including or positioning the control unit in the leadbody. This is in contrast to conventional systems in which the controlunit is typically embedded or positioned within a pulse generator orimplantable device that is separate from the lead body. The control unitmay be positioned within the lead body in close proximity to thetransducer contacts, at the distal end of the lead body. By positioningthe control unit in close proximity to the transducer contacts, it ispossible to use filaments of smaller diameter due to the short distancebetween the control unit and the transducer contacts. This allows foraccommodation of a larger number of filaments and permits a greaternumber of transducer contacts to be present on the lead body. Inconventional systems, filaments of smaller diameter may not be used dueto the longer distance that they must travel, which causes the smallerdiameter wires to be less robust and unpredictable in their operability.

The control unit may be configured to receive control signals and sendcontrol signals. For example, the control unit may be configured toreceive input control signals and send output control signals. Thenumber of output control signals may be greater than the number of inputcontrol signals. The input control signals may be sent from a devicethat generates at least one signal. The device may be a medical-relateddevice that supplies input signals to the control unit. The device maycomprise a pulse generator. The device may also comprise an energysource to energize the pulse generator. In some embodiments, the controlunit may be constructed and arranged to derive its energy from theenergy source of the device. In one embodiment, the energy source of theimplantable device is a battery.

The device may be an implantable device. The device may be at leastpartially implantable into a subject, such as a human or other mammal.For example, the device may be implantable in the chest region of asubject. The device may be surgically put in place, and may also besurgically removable. At least one of the input control signal and theoutput control signal may be in the form of a waveform, such as astimulus waveform. The control unit may provide at least one of powerharvesting, electrical stimulus generation, optical stimulus generation,pulse generation, pulse shaping, pulse pass-through, multiplexing,charge balance shaping, and impedance measurement or sensing to measuretherapy effectiveness (for example, charge delivery). The control unitmay be configured to harvest power from the implantable device toenergize the control unit. The implantable device may provide at least aportion of the power to the control unit to energize the control unit.In certain embodiments, the implantable device may provide the power tothe control unit to energize the control unit.

The control unit may be configured to send at least one electricalsignal to at least one transducer contact at a distal end of the leadbody. The control unit may be configured to send at least one electricalsignal to each of the transducer contacts at a distal end of a leadbody. The transducer contacts, in this example, may be electrodes. Thecontrol unit may also be configured to send at least one optical signalto each of the transducer contacts at a distal end of a lead body. Thetransducer contacts in this example, may be optical output sites. Thesemay be used in applications such as optical excitation or modulation,more specifically, optical neuromodulation or optogenetic modulation.

The control unit may also provide closed loop control using transducersensing to modify control and stimulation functions. The control unitmay send at least one output control signal to at least one transducercontact. The transducer contact may then transmit at least one inputsignal to the control unit. The control unit may then further send atleast one output signal to at least one transducer contact, based on theat least one input signal. The control unit may also send the at leastone output signal to at least one transducer contact based on a controlfunction of the control unit.

The control unit may also be capable of performing decision making Thecontrol unit may be configured to communicate or send signals back tothe device, for example, the implantable device. In addition or in thealternative, the control unit may be configured, to receive signals fromthe device. The control unit may also be configured to communicate orsend signals to the transducer contacts. In addition or in thealternative, the control unit may be configured to receive signals fromthe transducer contacts.

Power to the control unit may be harvested from the implantable device.The power may be applied using lead wires between the implantable deviceand the control unit. In certain embodiments, AC-coupled only signalsmay be used to ensure or reduce damage due to any wire breakage orleakage, or any other event that may cause tissue damage if a DC signalwere to be applied. Power may also be provided wirelessly. This may beaccomplished using coupled radio-frequency antennas or acoustictransducers.

In certain embodiments the control unit may be a bio-compatible by anintegrated ultra high density integrated circuit-based device. Thecontrol unit may be enclosed or encapsulated by a material, such as athin-film hermetic material, that may provide a hermetic seal. Thecontrol unit may also comprise hermetic feedthroughs at a high densityof, for example, greater than 10 feedthroughs/mm². The material may be abio-compatible material. The material may be deposited using asputtering or atomic layer deposition process. The contacts of thecontrol unit and the input and output locations may also be composed ofbio-compatible materials.

Typically, conventional equipment used in the applications disclosed maycomprise a titanium enclosed implantable medical device which compriseselectronics, battery, processor, and stimulatory circuitry. An electrodelead is connected to the implanted device, and carries a stimulus pulseto the distal end of the lead, where current may exit the lead throughtransducer contacts and enters the tissue that it is in contact with.Four to eight transducer contacts (electrodes) are included on existingdeep-brain stimulators, while spinal simulators may have eight to 16contacts per lead. It has not been possible to provide greater thaneight transducer contacts electrodes on a deep brain stimulator lead;similarly, it has not been possible to provide greater than 16transducer contacts (electrodes) on a spinal stimulator lead. This isbecause there is generally the requirement of one-to-one mapping of leadconductors (or wires) to output transducer contacts (electrode sites).Due to the constraints on the size (width or diameter) of the lead body,it has not been possible to accommodate more than 16 lead wires, whichonly allows for 16 transducer contacts. The small number of transducercontacts may lead to over-stimulation of non-target areas, which mayresult in severe side effects for the subject. These severe side effectsmay include difficulty with speech and memory loss. For spinal cordstimulation, lead migration after surgery reduces therapy effectiveness,which could be overcome by using the systems and methods of the presentdisclosure.

The control unit of the present disclosure alleviates the constraintsassociated with conventional equipment by placing a control unit withinthe lead body in close proximity to the transducer contacts. The controlunit may be configured to have multiplexing functionality, which allowsfor a greater number of lead wires between the control unit and thetransducer contacts. The diameter of the lead wires between the controlunit and the transducer contacts, due to the shorter distancetherebetween, may be much smaller than those used in conventionalequipment. Thus, more wires, or filaments, may be accommodated, allowingfor more transducer contacts to be used. In some embodiments of theinvention, the transducer contacts of the present disclosure may havethe same amount of surface area as the conventional equipment. However,the greater number of transducer contacts, which may be controlledindividually, allows for finer control of the delivery of electricalsignals to a desired or predetermined area.

In certain embodiments, a physiological electrical lead body isprovided. The lead body may comprise a plurality of transducer contactsin close proximity to an end of the lead body. The lead body may alsocomprise a control unit positioned within the lead body in closeproximity to the plurality of transducer contacts. The control unit maybe in communication with the plurality of transducer contacts. Thecontrol unit may be constructed and arranged to enable precise deliveryof signals to a predetermined treatment site. The control unit maycomprise at least one electrical input contact and a plurality ofelectrical output contacts. The quantity of electrical input contacts istypically greater than the quantity of electrical output contacts.

In some embodiments, the diameter or width of the lead body is less thanabout 2 mm. In certain embodiments, the diameter or width of the leadbody is less than about 2.0 mm. In other embodiments, the diameter orwidth of the lead body is less than about 1.3 mm. In specific examples,it may be 1.27 mm. The plurality of transducer contacts may comprise aquantity of transducer contacts to allow flexibility in the delivery ofsignals to a target site or a pretreatment area. The transducer contactsmay be of a quantity to allow for precise delivery of signals to apredetermined target site. The precise delivery may be accomplishedthrough the use of more transducer contacts in a given area thanconventional devices. This higher density of transducer contacts allowsfor delivery of signals to smaller and more targeted areas. Theplurality of transducer contacts may comprise at least about eighttransducer contacts, but may be up to 64 transducer contacts, or higher.In some embodiments, the distance between the control unit and the endof the lead body is such that it allows for adequate reliability of thefilaments between the control unit and the transducer contacts. Incertain embodiments, the distance is less than about 5 cm and, incertain other embodiments, may be less than about 2 cm. The filamentsmay have a diameter of less than about 0.150 mm.

The transducer contacts may be in a form that allows them to transmit asignal. For example, a transducer contact may be in a form to transmitan electrical signal by way of an electrode contact. In another example,a transducer contact may be in a form to transmit an optic signal by wayof an optical contact. The transducer contacts may be, for exampleelectrode contacts, optical contacts, acoustic contacts, induction coilcontacts, magnetic coil contacts, and combinations thereof. Theplurality of transducer contacts may be referred to as an array oftransducer contacts. Each transducer contact of the array may be thesame type of contact; for example, each transducer contact may be anelectrode contact. Alternatively, the array may include transducercontacts of more than one type. For example, the array may comprisealternating electrode contacts and optical contacts, or alternatingelectrode, optical and acoustic contacts. Any pattern of contacts may beused such that they may achieve a desired result of precisely targetinga particular treatment site of a subject. An array of transducercontacts may be processed by a control unit to present a waveform to anarray of output signals.

The transducer contacts may also be in a form that allows them toperform one or more actions. The transducer contacts may be disposed toperform at least one of sensing at least one parameter of thephysiological process, transmitting at least one parameter of thephysiological process, stimulating the physiological process, orinhibiting the physiological process. In one embodiment, the controlunit is constructed and arranged to record at least one parameter of thephysiological process. For example, the transducer contacts may be atleast one of a sensor, a recorder, a transmitter, a stimulator, and aninhibitor. Each transducer contact of an array may be the same type oftransducer contact. For example, each transducer contact may be astimulator. Alternatively, the array may include transducer contacts ofmore than one type. For example, the array may comprise alternatingsensors and stimulators. In other examples, the array may comprisealternating sensors, stimulators, and recorders. Any pattern of contactsmay be used such that they may achieve a desired result of preciselytargeting a particular treatment site of a subject.

Parameters that may be sensed or transmitted may include electricalresponses, blood pressure, heart rate, temperature, and pressure.Parameters may also include other physiological properties that may beuseful in treatment of a subject or in diagnostic testing of a subject.

In some embodiments, the control unit of the system is configured toreceive at least one first input signal from the implantable device andto transmit a plurality of output signals to the plurality of transducercontacts. The plurality of output signals may be based at least in parton the at least one first input signal from the implantable device andon a control function of the control unit. In some embodiments, thecontrol unit is further configured to receive at least one signal fromthe plurality of transducer contacts, and the plurality of outputsignals is modulated in response to the at least one signal from theplurality of transducer contacts.

The electrical lead body may be configured to be connectable to animplantable device. The implantable device may comprise an energysource. The implantable device may be constructed and arranged toprovide a signal.

In some embodiments, a method is provided for treating a condition in asubject. The method may comprise utilizing the control unit in theelectrical lead body of the present disclosure. The method may comprisegenerating a first input signal from an implantable device. The methodmay further comprise transmitting the first input signal from theimplantable device to a control unit positioned in an electrical leadbody as described in this disclosure. A plurality of output signals maybe generated based on the first input signal from the implantabledevice. The plurality of output signals may also be generated based on acontrol function of the control unit. The plurality of output signalsmay be transmitted from the control unit to a plurality of transducercontacts on the electrical lead body. This method may provide precisedelivery of signals to a predetermined treatment site, for example, on asubject.

In some embodiments, the method may further comprise transmitting atleast one second input signal from the plurality of transducer contactsto the control unit. In some embodiments, modulation of at least oneparameter of the plurality of output signals in response to the at leastone second input signal from the plurality of transducer contacts isperformed. The at least one second input signal may be a plurality ofsecond input signals. An array of transducer contacts, such as an arrayof sensors, may be utilized to provide a plurality of input signals fromthe plurality of transducer contacts to the control unit. This maypresent a waveform to an array of output signals. Recording of the atleast one electrical signal from the plurality of electrode contacts mayalso be performed. In some embodiments, the electrode contacts of thecontrol unit may perform at least one of sensing, transmitting,stimulating, and inhibiting. In some embodiments, the method may furthercomprises energizing the control unit from the implantable device.

As shown in FIG. 1, a portion of an electrical lead body 100 isprovided. At an end of electrical lead body 100 a plurality of electrodecontacts 102 and a control unit 104 is positioned. Electrical lead bodymay receive a signal through one or more wires 112 from a device, suchas an implantable device, or another external source.

FIG. 2A shows system 20 for modulating a physiological process.Implantable device 206 may comprise a power source and a pulse generatorand communicates by way of wires 212 in electrical lead body 200.Electrical lead body 200 comprises wires 212 and distal portion 208.Distal portion 208 comprises plurality of transducer contacts 202 whichare in close proximity to distal end 210 of distal portion 208 ofelectrical lead body 200. Distal portion 208 also comprises control unit204 which is positioned within electrical lead body 200 and in closeproximity with plurality of transducer contacts 202. Control unit 204 isin communication with transducer contacts 202 and implantable device206. At least a portion of distal portion 208 may be implanted into asubject, for example, a brain of a subject. Implantable device 206 maybe implanted into any portion of the subject that would allow forappropriate operation of the device. For, example, implantable device206 may be implanted into the subject's chest or in a portion of an ear,similar to a cochlear implant. Alternatively, implantable device 206 mayalso be constructed so that it may be affixed to the subject externally.Electrical lead body 212 may also be at least partially implantablewithin a subject.

Additionally, as shown in FIG. 2B, more than one distal portion 208 maybe in communication with implantable device 206 by way of wires 212. Asshown in FIG. 2B, two distal portions 208 are shown, which are derivedfrom lead body 212. Each distal portion 208 comprises control unit 204which is positioned within electrical lead body 200 and in closeproximity with plurality of transducer contacts 202. Each control unit204 is in communication with transducer contacts 202 and implantabledevice 206. The bifurcation of wire 212 may occur anywhere along wire212. Additionally, system 20 may comprise any number of distal portions208 to provide the desired physiological effect.

Distal portion 208 may be of various sizes and configurations toaccommodate the target area of the subject. For example, in applicationsthat include transmitting signals to the brain, the distal portion maybe of a size to minimize disruption to the brain. In other applications,such as those related to spinal treatments, the distal portion may be ofa greater width or height to accommodate the larger targeted area. Thiscan be shown in FIG. 2C and FIG. 2D. As shown in FIG. 2C and FIG. 2D,system 20 for modulating a physiological process. Implantable device 206may comprise a power source and a pulse generator and communicates byway of wires 212 in electrical lead body 200. Electrical lead body 200comprises wires 212 and distal portion 208. Distal portion 208 comprisesplurality of transducer contacts 202 which are in close proximity todistal end 210 of distal portion 208 of electrical lead body 200. Distalportion 208 also comprises control unit 204 which is positioned withinelectrical lead body 200 and in close proximity with plurality oftransducer contacts 202. In certain embodiments, such as in spinaltreatments, the configuration of FIG. 2C may be preferred. In otherembodiments, such as treatments targeting the brain, the configurationof FIG. 2D may be preferred.

In certain embodiments, the system of the disclosure may be configuredto deliver spatially targeted signals from array of transducer contacts30. FIGS. 3A-3C exemplarily show a portion of the system for modulatinga physiological process. The control unit may dynamically select orestablish one transducer contact or a group or array of transducercontacts as a source of an output to the area to be treated. Transducercontacts may be selected from the group consisting of electrodescontacts, optical contacts, acoustic contacts, induction coil contacts,magnetic coil contacts, and combinations thereof.

For example, in FIG. 3A, dark grey transducers, including transducercontacts 320 may be electrode contacts that receive an output signalfrom the control unit and deliver the output signal to the treatmentarea. The output signal may function as a stimulus signal to stimulatethe treatment area. Light grey transducers, including transducers 322,may be sensors that may sense a particular parameter of the treatmentarea and send one or more input signals to the control unit. The controlunit may process the one or more input signals and, in response to theone or more sensor signals, may send one or more output signals back totransducers 320.

Alternatively, FIG. 3A may be a representative of an array comprisingreference transducer contacts 322 and active transducer contacts 320that deliver a pattern of stimulus from the control unit.

In certain embodiments, such as in FIG. 3A not all transducer contactsare in use at any given time. For example, in FIG. 3A, only eight of the40 transducer contacts are in use, but more, less, none, or all of thetransducer contacts may be in use at a given time, and this may changeor stay the same during a given treatment.

FIG. 3B shows an alternate pattern of transducer contacts that may havebeen adjusted relative to the initial pattern. The adjustment may havebeen performed based on initial input signals from sensors 322 of FIG.3A. The adjustment may also have been performed, in addition, oralternatively, based on a control function of the control unit. FIG. 3Cshows an alternate pattern which may be based on input signals fromsensors 322 of FIG. 3B. The adjustment may also have been performed, inaddition, or alternatively, based on a control function of the controlunit. Through adjustments of the spatial positioning and charge densityof the transducer contacts, the electrical stimulation volume of theelectrical lead can be carefully controlled to enable precise deliveryof signals to a predetermined treatment area.

The disclosure is not limited in its application to the details ofconstruction and arrangement of components, systems or subsystems setforth in the description, including the various examples or asillustrated in the drawings. The disclosure is capable of otherembodiments and of being practiced or of being carried out in variousways. The terms used herein for the purpose of description should not beregarded as limiting. The use of the terms “comprising,” “including,”“carrying,” “having,” “containing,” “involving,” and the like are to beunderstood to be open-ended, that is, to mean including but not limitedto. Only the transitional phrases “consisting of” and “consistingessentially of ” shall be closed or semi-closed transitional phrases,respectively, as set forth, with respect to the claims.

Use of ordinal terms such as “first,” “second,” “third,” and the like inthe specification and claims to modify an element does not by itselfconnote any priority, precedence, or order of one element over anotheror the temporal order in which acts of a method are performed, but areused merely as labels to distinguish one element having a certain namefrom another element having a same name, but for use of the ordinalterm, to distinguish the elements.

1-10. (canceled)
 11. A system for modulating a physiological process,comprising: an implantable device comprising an energy source, theimplantable device constructed and arranged to provide a signal; and anelectrical lead body connected to the implantable device and comprising:a plurality of transducer contacts in close proximity to an end of theelectrical lead body; a control unit positioned within the lead body inclose proximity to the plurality of transducer contacts and constructedand arranged to enable precise delivery of signals to a predeterminedtreatment site, the control unit configured to receive at least onefirst input signal from the implantable device and to transmit aplurality of output signals to the plurality of transducer contacts, andfurther configured to receive at least one second input signal from theplurality of transducer contacts, the control unit comprising: at leastone electrical input contact; and a plurality of electrical outputcontacts, wherein a quantity of the electrical output contacts isgreater than a quantity of the electrical input contacts. wherein theplurality of output signals is modulated in response to the at least onefirst input signal from the plurality of transducer contacts, and theplurality of output signals is based at least in part on the at leastone first input signal from the implantable device and on a controlfunction of the control unit.
 12. The system of claim 11, wherein theplurality of transducer contacts are disposed to perform at least one ofsensing at least one parameter of the physiological process,transmitting at least one parameter of the physiological process,stimulating the physiological process, and inhibiting the physiologicalprocess.
 13. The system of claim 12, wherein the control unit isconstructed and arranged to record at least one parameter of thephysiological process.
 14. The system of claim 11, wherein a diameter ofthe electrical lead is less than about 2 mm.
 15. The system of claim 11,wherein the plurality of transducer contacts comprises at least about 8transducer contacts.
 16. The system of claim 11, wherein a distancebetween the control unit and the end of the lead is less than about 5cm.
 17. The system of claim 11, wherein the control unit is encapsulatedwith a material.
 18. The system of claim 17, wherein the encapsulationwith the material provides a hermetic seal.
 19. The system of claim 11,wherein the plurality of the electrical output contacts are connected tothe plurality of transducer contacts by a plurality of filaments, eachfilament having a diameter of less than about 0.150 mm.
 20. The systemof claim 11, wherein the electrical lead is implantable in a subject.21. The system of claim 11, wherein the implantable device providespower to the control unit to energize the control unit. 22-23.(canceled)
 24. The system of claim 11, wherein the plurality oftransducer contacts are selected from the group consisting of electrodecontacts, optical contacts, acoustic contacts, induction coil contacts,magnetic coil contacts, and combinations thereof.
 25. A method oftreating a condition in a subject, comprising: generating a first inputsignal from an implantable device; transmitting the first input signalfrom the implantable device to a control unit positioned in anelectrical lead body comprising a first end and a plurality oftransducer contacts in close proximity to the first end; generating aplurality of output signals based on the first input signal from theimplantable device and on a control function of the control unit;transmitting the plurality of output signals from the control unit tothe plurality of transducer contacts to provide a precise delivery ofsignals to a predetermined treatment site; transmitting at least onesecond input signal from the plurality of transducer contacts to thecontrol unit; and modulating at least one parameter of the plurality ofoutput signals in response to the at least one second input signal fromthe plurality of transducer contacts. 26-27. (canceled)
 28. The methodof claim 25, further comprising recording the at least one second inputsignal from the plurality of transducer contacts.
 29. The method ofclaim 25, wherein each of the plurality of transducer contacts performsthe act of at least one of sensing, transmitting, stimulating, andinhibiting.
 30. The method of claim 25, wherein the plurality oftransducer contacts are selected from the group consisting of electrodescontacts, optical contacts, acoustic contacts, induction coil contacts,magnetic coil contacts, and combinations thereof.
 31. The method ofclaim 25, further comprising energizing the control unit from theimplantable device.